Duns Number:421343701
Device Description: The stimulator may be used for the following:Symptomatic relief of chronic intractable pa The stimulator may be used for the following:Symptomatic relief of chronic intractable pain，Post traumatic pain，post surgical pain，Relaxation of muscle spasm， Increase blood flow circulation，Prevention or retardation of disuse atrophy， Muscle re-education， Maintaining or increasing range of motion.，Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Catalog Number
-
Brand Name
Famidoc
Version/Model Number
FDES108A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113010,K113010
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
e9cb2091-d5dc-41de-9b5a-06379491f31d
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
November 05, 2016
Package DI Number
16970389630109
Quantity per Package
40
Contains DI Package
06970389630102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |